Quality · Document management
A document management system for GMP must control the entire document life cycle: who requests it, who drafts and approves it with a signature, who read it, which version was in force on each date and when it became obsolete. FastOfi does this within the integrated management system, with a history of every change.
Life cycle
Each stage leaves its record with an owner, date and signature. So you can answer in minutes which version was used in a batch or who has not read a new procedure.
Anyone can ask to create or change a document, and the request is recorded with its reason.
The owner writes the new version. Sophia can propose a draft for the person to review.
The document goes through review and is approved with an electronic signature.
It is sent to the roles that need to know it, and each person confirms they have read it.
It becomes effective with its code and version; previous versions are kept with their history.
When it is replaced or withdrawn, the previous version becomes obsolete and is no longer available for use.
What an audit asks for
These are the questions a GMP or ISO 9001 auditor usually asks about document control, and where the answer lives.
| What the auditor asks | Where the evidence lives in FastOfi |
|---|---|
| Which version of the procedure was in force when this batch was manufactured? | Each version has its effective dates and its approval history. |
| Do staff know the updated procedure? | Distribution records who it was sent to and who confirmed reading it. |
| Who approved the change and why? | The request stores the reason, and the approval carries an electronic signature. |
| How do you control external documents? | Standards, certificates and supplier manuals are recorded as external documents with periodic review. |
| How do you prevent an obsolete version from being used? | When a new version is approved, the previous one becomes obsolete and is taken out of use. |
Document management by industry
Document control is a common requirement of GMP for pharmaceuticals, cosmetics and food, and of ISO 9001. What changes are the documents audited most.
Manufacturing procedures, manufacturing instructions, specifications and batch records under change control.
The cosmetics GMP checklist reviews the system documentation, the records and their retention.
Cleaning and disinfection, pest control, supplier and training programs, with their records up to date.
Frequently asked questions
It is a system that controls the creation, approval, distribution, versions and withdrawal of an organization's documents, recording who performed each step. In a regulated plant it also shows which version was in force at any given time.
A folder stores files. A document management system controls who can approve them, records the signature, sends the document to whoever must read it, confirms the read and prevents an obsolete version from being used.
Yes. Document control is a requirement of both. FastOfi organizes documents within the integrated management system; conformity is assessed by the auditor or the authority, not by the software.
Yes. Current documents are uploaded with their code and version, and from there changes follow the request, approval and distribution workflow.
Sophia can prepare a document draft with your confirmation. Review, approval and signature are always done by a person.
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